A Phase I/II Study of PDC-1421 for Treating Depression in Cancer Patients
Key facts
- Where
- Los Angeles, United StatesSee the site
- Phase
- Phase 1/2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 21 and 85 years old?
Source: NCT03833206, who can take part
Where in United States
- Cedars-Sinai Health SystemLos Angeles, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- BioLite, Inc.
- Trial code
- NCT03833206
- Record updated
- 20 April 2026
- Original description
The purpose of this study is to evaluate the safety and the effective doses of PDC-1421 in cancer patients with depression.Read full original descriptionShow less
A Phase I/II Study of PDC-1421 for Treating Depression in Cancer Patients: Part I Dose Escalation
The purpose of this study is to evaluate the safety and the effective doses of PDC-1421 in cancer patients with depression.
Exclusion: Have a current or previous diagnosis of or history consistent with obsessive-compulsive disorder, posttraumatic stress disorder, bipolar I or II, manic or hypomanic episodes, schizophrenia, major Axis II disorders which might compromise the study, or major depression with psychotic symptoms, as assessed using the MINI International Neuropsychiatric Interview (MINI Plus); Use of any antidepressant medication in the last 2 weeks before visit 1 (4 weeks for fluoxetine); Currently being treated with tamoxifen; Have a documented history of an intellectual disability; Subjects who were non-responsive to two or more courses of antidepressant medications given at an adequate dosage* for symptom treatment within four weeks, or by the judgment of the investigator considered to have treatment resistant depression (TRD), or a history of electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS) or psychosurgery within the last year; Have a history of any seizure disorder; Have a history of substance dependence/abuse** within the past 6 months or a positive drug screen result during the screening period; Have a history of severe allergies to more than 1 class of medication or multiple adverse drug reactions; * An adequate dosage of the antidepressant medication is defined as the average of the usual dose (mg/day) recommended in American Psychiatric Association (APA) Practice Guideline for the Treatment of Patients with Major Depressive Disorder, Third Edition. E.g. the usual dose of Citalopram is 20-60 mg/day, the adequate dosage is 40 mg/day; Any clinically significant abnormal vital sign, ECG, or laboratory values as determined by the investigator which might interfere with the study; ** Tobacco is excluded here, and alcohol abuse is defined as average pure alcohol intake is more than 112 g (for male) or 56 g (for female) per week and/or with Alcohol withdrawal syndrome. Pure alcohol intake =% (Concentration or alcohol content) x c.c. (volume)x 0.79 (density of alcohol). Result of serum ethanol test should be equal to or lower than 10.0 mg/dL to be determined as eligible for the trial. If test result is between 10.1 to 29.9 mg/dL, only one re-test is allowed per subject to meet the criterion. Subject with test result equal to or higher than 30.0 mg/dL is to be excluded; Have a high suicidal risk as assessed using the Columbia-Suicide Severity Rating Scale (C-SSRS). High suicidal risk is indicated by:; A positive response to question 4 or 5, indicating endorsement of suicidal ideation with at least some intent to act in the past month; and/or; A positive response to part two of question 6, indicating the presence of any suicidal behavior in the past 3 months.
Eligibility Criteria; 21 to 85 Years of age; Diagnosis of Stage I, II or III cancer; Histologically-proven malignancy; Receiving or within one year of having received cancer treatment with radiation and/or chemotherapy; Montgomery and Åsberg Depression Rating Scale (MADRS) ≥ 20 (moderate to severe depressive symptoms); Duration of depressive symptoms ≥ 2 weeks by patient report; No active/acute suicidality requiring immediate care or psychiatric hospitalization; Sufficient English language proficiency to complete all assessments without assistance; Able to swallow pills; No severe anemia, defined as hemoglobin < 10 g/dL; No history of multiple adverse drug reactions or allergy to study drugs; Not pregnant; No history of head trauma; No history of epilepsy; No other concurrent antidepressant medications.